Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001022550
Ethics application status
Approved
Date submitted
11/08/2015
Date registered
1/10/2015
Date last updated
1/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of outcomes associated with adding a home-based exercise program via two home visits, to a group exercise program and home exercise program for clients attending outpatient rehabilitation with balance deficits.
Scientific title
For clients attending outpatient rehabilitation with balance deficits, does providing them with an additional two home visits to set them up with a home exercise program (Otago) along with usual care (1:1 centre based therapy, balance group program and possible home exercise program given to them at the centre) provide them with improvements in physical balance outcomes compared to those who complete usual care (1:1 centre based therapy and balance group program and possible home exercise program given to them at the hospital)?
Secondary ID [1] 286623 0
Nil known
Universal Trial Number (UTN)
U1111-1169-7856
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decreased balance/falls 295307 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295579 295579 0 0
Physiotherapy
Injuries and Accidents 296233 296233 0 0
Other injuries and accidents
Public Health 296234 296234 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received usual care (see in control treatment) and two home visits to individually tailor a home exercise program which was provided and shown to them at their home. They received a visit from a physiotherapist who was not involved in delivering any of the exercise groups. The physiotherapist chose suitable exercises from a subset of the Otago Balance Program (Campbell et al, 1997) based on the participant’s assessment results. Exercises included things such as sit to stand, 1/4 squats, calf rasies, toe raises, sideways walking, leg curl, standing hip abduction, single leg stand, walking, walking and turning around, heel/toe standing, heel/toe walking, heel walking, toe walking and stair walking. The initial home visit was conducted the week before or after commencing usual care, and was followed by a visit between weeks four and five of the intervention to continue to motivate the participant, encourage adherence with the home exercise program, and to follow up and progress the home exercise program as necessary. Participants were shown the exercise in their home environment, received a written copy of their exercises, and were asked to complete an exercise diary each day to record which exercises were completed. They were asked to complete exercises for between 30 mins to 1 hour per day from the time of the first home visit until the 3 month follow-up asessment. Home visit were approximately 1 hour in duration.
Intervention code [1] 292082 0
Rehabilitation
Comparator / control treatment
The control group received usual care, which involved eight sessions once a week for 8 weeks in a strength and balance exercise group at the rehabilitation centre and a home exercise program determined by their treating therapist (either a physiotherapist or exercise physiologist). A written, individually tailored and taught home exercise program was given to the client at the hospital at the discretion of the treating therapist. Frequency and duration of this home exercise program varied depending on the advise given from the treating therapist. The exercises varied depending on needs of the client's and were given as per usual care. No diary was kept by clients to determine if they were adhering to this home exercise program. An exercise physiologist, physiotherapist or allied health assistant conducted the group exercise program, which consisted of static and dynamic balance exercises and mobility and strengthening exercises. There was a ratio of two therapists to six participants. It was run in the gym located within the rehabilitation centre. Each group was one hour in duration and participants were considered adherent to the program if they attended at least six sessions within an eight week period.
Control group
Active

Outcomes
Primary outcome [1] 295288 0
Balance Outcome Measure for Elder Rehabilitation (BOOMER)
The BOOMER is a combination of four clinical balance tests: the step test, Timed Up and Go test, Functional Reach Test, and static standing balance with feet together and eyes closed. The step test assesses participant’s ability to place one foot onto a 7.5-cm-high step and then back down to the floor repeatedly, as fast as possible, for 15 seconds. The score is the number of steps completed in the 15-second period for each lower extremity (Mercer et al, 2009). An average of 2 trials is recorded. Participants unable to stand unsupported are given a score of 0 for both lower extremities (Mercer et al, 2009). The Timed Up and Go (TUG) test assesses the time that a participant takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The Functional Reach test assesses the maximum distance participant’s can reach forward while standing in a fixed position.Two practice trials are completed and then one trial with distance recorded. The Static Standing with feet together and eyes closed test assesses the time a participant can stand unsupported with their feet together and eyes closed to a maximum of 30 seconds. Three trials are completed. However, if a participant achieves 30 seconds on the first trial, remaining trials are automatically scored as 30 seconds. Times from three trials are added together. A score out of sixteen is determined by scoring each item out of four according to the table below. Refer to attachement with table illustrating the scoring system used.
The test takes approximately 10 minutes to complete. Each component of the test has established reliability and the overall measure has high internal consistency with a minimum clinically significant change of three points (Haines et al 2007). Refer to attachment 1 for BOOMER table of scoring.
Timepoint [1] 295288 0
- baseline (before the start of the intervention, week 0)
- within two weeks of completing the intervention (week 9)
- at 3 months (week 21) following completion of the group to determine maintenance of any benefits.
Secondary outcome [1] 315270 0
Force Platform measures of balance
A Neurocom Balance Master (Liston &Brouwer, 1996) will be used and three tests will be performed – 1) Clinical Test of Sensory Interaction of Balance (CTSIB) - which is a test of postural sway of 30 seconds duration, assessing steadiness during standing on a firm surface with eyes open and then eyes closed; then on a foam surface with eyes open and eyes closed; 2) Limits of Stability test – in this test the participant stands and leans in eight different directions as far as possible towards targets (set at straight ahead, to the left, to the right, backwards, and 45 degrees between each of these targets); 3) Step and Quick Turn – where the participant takes two steps, turns then returns to the starting position. This was repeated 3 times turning to the right and then turning to the left.
Timepoint [1] 315270 0
- baseline (before the start of the intervention, week 0)
- within two weeks of completing the intervention (week 9)
- at 3 months (week 21) following completion of the group to determine maintenance of any benefits.
Secondary outcome [2] 317212 0
Sit to stand task:
This is a functional test were participants are asked to stand up and sit down five times as quickly as possible from a 45cm high chair and the time taken to complete the task is documented. Participants are allowed to push up on their arms if required.
Timepoint [2] 317212 0
- baseline (before the start of the intervention, week 0)
- within two weeks of completing the intervention (week 9)
- at 3 months (week 21) following completion of the group to determine maintenance of any benefits.

Eligibility
Key inclusion criteria
Patients were included if they met the following criteria: were clients at the rehabilitation centre and were referred for management of balance and strength problems. Participants were not excluded if their first language was other than English; interpreters were available at the centre for participants from culturally and linguistically diverse backgrounds.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they had a cognitive impairment (as measured by an Abbreviated mental Test Score of less than or equal to 7) or if they were not safe to participate in a balance exercise group.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A prospective, parallel group randomised control trial with 1:1 allocation ratio was conducted. The study was conducted at a rehabilitation centre in the Northern Metropolitan region of Melbourne. The clients were recruited from a Community Therapy Service, a short-term, outpatient, goal oriented, inter-disciplinary service with a rehabilitation focus offered by the centre. The service was provided either at the client’s homes or at the rehabilitation centre. Following referral to the physiotherapy/exercise physiology department at the centre for management of balance and strength problems, patients were asked if they were willing to participate in this trial. Ethics approval was obtained from the Health Service prior to commencement of patient recruitment and written informed consent to take part in the trial was obtained from participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random numbers table was used to generate the allocation sequence of participants entered into the trial. Group allocations were sealed in consecutively numbered opaque envelopes by a member of the research team not involved in the recruitment, assessment or treatment of participants. Participants were randomised prior to the baseline assessment, by opening the next envelope in the sequence. The envelopes where opened by a health professional working at the Health Services but who was based at a separate campus and who was not involved in either the recruitment, assessment or treatment of the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation - A power analysis was performed based on current patient data from the balance and strength training group, using the foam eyes closed measure (Neurocom). Assuming a 20% greater improvement in the experimental group relative to the control group, with 80% power and alpha set at 0.05, a sample of 17 patients / group will be required. Allowing for 20% sample attrition (based on our clinical experience and other similar exercise studies), we will recruit 22 patients / group (ie 44 patients overall).
The primary outcome measure will be the BOOMER score, and other force platform and clinical measures will be secondary outcomes. Repeated measures between group ANOVA will be used to identify interaction effects between group and time (p<0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
2/11/2011
Date of last participant enrolment
Anticipated
31/12/2012
Actual
30/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4294 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 9828 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 291453 0
Hospital
Name [1] 291453 0
Northern Health Human Research Committee Small Research Grant
Country [1] 291453 0
Australia
Primary sponsor type
Individual
Name
Craig Whitbourne
Address
Broadmeadows Health Service, Physiotherapy Department - 35 Johnstone st, Broadmeadows, Vic, 3047
Country
Australia
Secondary sponsor category [1] 290130 0
Individual
Name [1] 290130 0
Kate Lawler
Address [1] 290130 0
Northern Hospital - 185 Copper st, Epping, Vic, 3076
Country [1] 290130 0
Australia
Secondary sponsor category [2] 290132 0
Individual
Name [2] 290132 0
Keith Hill
Address [2] 290132 0
School of Physiotherapy and Exercise Science,
Curtin University,
GPO U1987,
Perth
WA 6845
Country [2] 290132 0
Australia
Secondary sponsor category [3] 290133 0
Individual
Name [3] 290133 0
Nora Sheilds
Address [3] 290133 0
School of Allied Health,
La Trobe University,
Plenty rd and Kingsbury Drive,
Bundoora
Vic 3086
Country [3] 290133 0
Australia
Other collaborator category [1] 278495 0
Individual
Name [1] 278495 0
Kenneth Koh
Address [1] 278495 0
Broadmeadows Health Service, Physiotherapy Department - 35 Johnstone st, Broadmeadows, Vic, 3047
Country [1] 278495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293005 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 293005 0
Ethics committee country [1] 293005 0
Australia
Date submitted for ethics approval [1] 293005 0
28/07/2011
Approval date [1] 293005 0
01/09/2011
Ethics approval number [1] 293005 0
LR - 19/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 500 500 0 0
/AnzctrAttachments/368461-PICF - informed consent form barcoded.doc
Attachments [2] 501 501 0 0
/AnzctrAttachments/368461-Ethics approval.pdf
Attachments [3] 564 564 0 0
/AnzctrAttachments/368461-BOOMER scoring table.docx

Contacts
Principal investigator
Name 56902 0
Mr Craig Whitbourne
Address 56902 0
Broadmeadows Health Service
Physiotherapy Department
35 Johnstone st
Broadmeadows
Vic 3047
Country 56902 0
Australia
Phone 56902 0
+61 3 83455252
Fax 56902 0
+61 3 83455616
Email 56902 0
[email protected]
Contact person for public queries
Name 56903 0
Craig Whitbourne
Address 56903 0
Broadmeadows Health Service
Physiotherapy Department
35 Johnstone st
Broadmeadows
Vic 3047
Country 56903 0
Australia
Phone 56903 0
+61 3 83455252
Fax 56903 0
+61 3 83455616
Email 56903 0
[email protected]
Contact person for scientific queries
Name 56904 0
Craig Whitbourne
Address 56904 0
Broadmeadows Health Service
Physiotherapy Department
35 Johnstone st
Broadmeadows
Vic 3047
Country 56904 0
Australia
Phone 56904 0
+61 3 83455252
Fax 56904 0
+61 3 83455616
Email 56904 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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